Spezialist Qualitätssicherung (m/w/d) mit hoher IT-Affinität (Pharma)
Core
Ensuring quality standards (GMP), validating IT systems (CSV), and managing building facilities in a pharmaceutical manufacturing environment.
Role type
Quality Assurance Specialist with IT and Facility Management responsibilities
Builds
Pharmaceutical products (liquid and semi-solid dosage forms) for clients
Domain
Pharmaceutical manufacturing / Quality Assurance / IT Systems / Facility Management
Required skills
GMP compliance, SOP creation, Computer System Validation (CSV), facility monitoring, calibration management, risk analysis (QRM/Nitrosamine), ERP administration, building maintenance coordination
Preferred skills
Natural sciences or engineering degree, IT administration basics, technical understanding of production plants, GMP documentation experience
Technologies
ERP systems, GMP documentation tools
Responsibilities
Plan and document equipment and room qualifications, monitor and coordinate calibration measures, create QRM and Nitrosamine risk analyses, coordinate Computer System Validation (CSV), manage building climate and ventilation systems, oversee maintenance contracts and external contractors, conduct internal GMP training
Seniority
Mid-level specialist
